Cognitive Behavioral Group Treatment for Obsessive-compulsive Disorder in Youth

NCT04891367 | Unknown

• 1 other identifier: GCBT OCD study - BUA
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Obsessive-compulsive disorder (OCD) is a debilitating disorder characterized by unwanted intrusive thoughts and disrupting repetitive rituals. Epidemiological studies estimate the prevalence of impairing OCD to be between 0.5-3.0 % in pediatric populations. Although OCD in youth is associated with substantial distress and functional impairment, access to evidence-based psychosocial treatments is limited. This is largely due to the fact that few clinicians are trained in the delivery of evidence-based treatments, such as exposure-based cognitive-behavioral therapy (CBT). Therefore it is of great importance to develop treatment programs that utilize therapist resources in the most efficient way. Exposure-based CBT delivered in the context of a group, rather than individually, is one such option. However, there are currently no evidence-based group OCD treatment manuals for youth available to clinicians in Denmark. Therefore this project addresses an important clinical need. We evaluate a group-based CBT protocol for the treatment of youth with OCD, benchmarking treatment outcomes against data from a previous trial evaluating individual-based CBT and by comparing outcomes against a short waiting list period. Further, we will explore the impact of group-based CBT over a 36-month open follow-up interval on general functioning, relapse, recurrence rates, and the need for other treatments. Finally, a brief youth questionnaire assessing overall symptom severity relevant for the evaluation of outcomes in pediatric OCD will be translated and validated for future clinical and research use in Denmark. The project will include 72 adolescents with a primary diagnosis of OCD referred for assessment and treatment at the OCD Clinic at Department of Child and Adolescent Psychiatry, Aarhus University Hospital, Psychiatry, Denmark. For benchmarking of treatment outcomes, the project will compare the results from the group-based CBT with data from 45 Danish patients previously enrolled in the individual-based CBT of the Nordic Long Term OCD Treatment Study at the same clinic.

Conditions

Obsessive-Compulsive Disorder; Cognitive Behavioral Therapy; Adolescent

Keywords

Cognitive behavioral Group Therapy; Youth; OCD

Outcome Measures

Primary Outcomes (18)

• The Children's Yale-Brown Obsessive Compulsive Scale

  The Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) 24 is a clinician rated, semi structured interview assessing past and current OCD symptom presentation as well as present OCD severity in patients aged 6-17 years. The instrument has a 72-item symptom checklist followed by 10 severity items, five for obsessions and five for compulsions (i.e., time occupied by symptoms, interference, distress, resistance, and degree of control over symptoms), with a total severity score ranging from 0 to 40. Higher scores indicate worse outcome. The instrument is the most frequently used to assess OCD in children and adolescents.

  Pre-waiting period of 2-16 weeks/pre-treatment

• The Children's Yale-Brown Obsessive Compulsive Scale

  The Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) 24 is a clinician rated, semi structured interview assessing past and current OCD symptom presentation as well as present OCD severity in patients aged 6-17 years. The instrument has a 72-item symptom checklist followed by 10 severity items, five for obsessions and five for compulsions (i.e., time occupied by symptoms, interference, distress, resistance, and degree of control over symptoms), with a total severity score ranging from 0 to 40. Higher scores indicate worse outcome. The instrument is the most frequently used to assess OCD in children and adolescents.

  Post-waiting period of 2-16 weeks/pre-treatment (within 2 weeks before the first group session)

• The Children's Yale-Brown Obsessive Compulsive Scale

  The Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) 24 is a clinician rated, semi structured interview assessing past and current OCD symptom presentation as well as present OCD severity in patients aged 6-17 years. The instrument has a 72-item symptom checklist followed by 10 severity items, five for obsessions and five for compulsions (i.e., time occupied by symptoms, interference, distress, resistance, and degree of control over symptoms), with a total severity score ranging from 0 to 40. Higher scores indicate worse outcome. The instrument is the most frequently used to assess OCD in children and adolescents.

  Mid-intensive-treatment (between session 7 and 8 in the intensive treatment period)

• The Children's Yale-Brown Obsessive Compulsive Scale

  The Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) 24 is a clinician rated, semi structured interview assessing past and current OCD symptom presentation as well as present OCD severity in patients aged 6-17 years. The instrument has a 72-item symptom checklist followed by 10 severity items, five for obsessions and five for compulsions (i.e., time occupied by symptoms, interference, distress, resistance, and degree of control over symptoms), with a total severity score ranging from 0 to 40. Higher scores indicate worse outcome. The instrument is the most frequently used to assess OCD in children and adolescents.

  Post-intensive-treatment (at termination of intensive treatment)

• The Children's Yale-Brown Obsessive Compulsive Scale

  The Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) 24 is a clinician rated, semi structured interview assessing past and current OCD symptom presentation as well as present OCD severity in patients aged 6-17 years. The instrument has a 72-item symptom checklist followed by 10 severity items, five for obsessions and five for compulsions (i.e., time occupied by symptoms, interference, distress, resistance, and degree of control over symptoms), with a total severity score ranging from 0 to 40. Higher scores indicate worse outcome. The instrument is the most frequently used to assess OCD in children and adolescents.

  Post-booster-treatment (at termination of booster treatment - 3 months after the last session in the intensive treatment period)

• The Children's Yale-Brown Obsessive Compulsive Scale

  The Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) 24 is a clinician rated, semi structured interview assessing past and current OCD symptom presentation as well as present OCD severity in patients aged 6-17 years. The instrument has a 72-item symptom checklist followed by 10 severity items, five for obsessions and five for compulsions (i.e., time occupied by symptoms, interference, distress, resistance, and degree of control over symptoms), with a total severity score ranging from 0 to 40. Higher scores indicate worse outcome. The instrument is the most frequently used to assess OCD in children and adolescents.

  6 months follow-up

• The Children's Yale-Brown Obsessive Compulsive Scale

  The Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) 24 is a clinician rated, semi structured interview assessing past and current OCD symptom presentation as well as present OCD severity in patients aged 6-17 years. The instrument has a 72-item symptom checklist followed by 10 severity items, five for obsessions and five for compulsions (i.e., time occupied by symptoms, interference, distress, resistance, and degree of control over symptoms), with a total severity score ranging from 0 to 40. Higher scores indicate worse outcome. The instrument is the most frequently used to assess OCD in children and adolescents.

  12 months follow-up

• The Children's Yale-Brown Obsessive Compulsive Scale

  The Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) 24 is a clinician rated, semi structured interview assessing past and current OCD symptom presentation as well as present OCD severity in patients aged 6-17 years. The instrument has a 72-item symptom checklist followed by 10 severity items, five for obsessions and five for compulsions (i.e., time occupied by symptoms, interference, distress, resistance, and degree of control over symptoms), with a total severity score ranging from 0 to 40. Higher scores indicate worse outcome. The instrument is the most frequently used to assess OCD in children and adolescents.

  24 months follow-up

• The Children's Yale-Brown Obsessive Compulsive Scale

  The Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) 24 is a clinician rated, semi structured interview assessing past and current OCD symptom presentation as well as present OCD severity in patients aged 6-17 years. The instrument has a 72-item symptom checklist followed by 10 severity items, five for obsessions and five for compulsions (i.e., time occupied by symptoms, interference, distress, resistance, and degree of control over symptoms), with a total severity score ranging from 0 to 40. Higher scores indicate worse outcome. The instrument is the most frequently used to assess OCD in children and adolescents.

  36 months follow-up

• The Health-Related Quality of Life in children and adolescents - revised

  The Health-Related Quality of Life in children and adolescents - revised (KINDL-R) measure key aspects of health related quality of life in children and adolescents. Separate questionnaires for ages 7-13 and 14-17 exist. A translated Danish version of the KINDL is available. This scale provides a more general evaluation of the young patient's overall well-being and thriving in several life areas: physical, emotional, self-esteem, family, friends, and school, representing the child's experiences during the past week. Each item is rated on a five-point Likert scale and all scores are transformed to a scale ranging from 0 to 100. All subscale scores are added together to form a total score, with higher scores indicating better outcome. The questionnaire has a disorder-related subscale that reflects the child's experience of OCD-related burden and this is not part of the total score. The primary outcome used in the present study is the KINDL-R self-report total score.

  Pre-waiting period of 2-16 weeks/pre-treatment

• The Health-Related Quality of Life in children and adolescents - revised

  The Health-Related Quality of Life in children and adolescents - revised (KINDL-R) measure key aspects of health related quality of life in children and adolescents. Separate questionnaires for ages 7-13 and 14-17 exist. A translated Danish version of the KINDL is available. This scale provides a more general evaluation of the young patient's overall well-being and thriving in several life areas: physical, emotional, self-esteem, family, friends, and school, representing the child's experiences during the past week. Each item is rated on a five-point Likert scale and all scores are transformed to a scale ranging from 0 to 100. All subscale scores are added together to form a total score, with higher scores indicating better outcome. The questionnaire has a disorder-related subscale that reflects the child's experience of OCD-related burden and this is not part of the total score. The primary outcome used in the present study is the KINDL-R self-report total score.

  Post-waiting period of 2-16 weeks/pre-treatment (within 2 weeks before the first group session)

• The Health-Related Quality of Life in children and adolescents - revised

  The Health-Related Quality of Life in children and adolescents - revised (KINDL-R) measure key aspects of health related quality of life in children and adolescents. Separate questionnaires for ages 7-13 and 14-17 exist. A translated Danish version of the KINDL is available. This scale provides a more general evaluation of the young patient's overall well-being and thriving in several life areas: physical, emotional, self-esteem, family, friends, and school, representing the child's experiences during the past week. Each item is rated on a five-point Likert scale and all scores are transformed to a scale ranging from 0 to 100. All subscale scores are added together to form a total score, with higher scores indicating better outcome. The questionnaire has a disorder-related subscale that reflects the child's experience of OCD-related burden and this is not part of the total score. The primary outcome used in the present study is the KINDL-R self-report total score.

  Mid-intensive-treatment (between session 7 and 8 in the intensive treatment period)

• The Health-Related Quality of Life in children and adolescents - revised

  The Health-Related Quality of Life in children and adolescents - revised (KINDL-R) measure key aspects of health related quality of life in children and adolescents. Separate questionnaires for ages 7-13 and 14-17 exist. A translated Danish version of the KINDL is available. This scale provides a more general evaluation of the young patient's overall well-being and thriving in several life areas: physical, emotional, self-esteem, family, friends, and school, representing the child's experiences during the past week. Each item is rated on a five-point Likert scale and all scores are transformed to a scale ranging from 0 to 100. All subscale scores are added together to form a total score, with higher scores indicating better outcome. The questionnaire has a disorder-related subscale that reflects the child's experience of OCD-related burden and this is not part of the total score. The primary outcome used in the present study is the KINDL-R self-report total score.

  Post-intensive-treatment (at termination of intensive treatment)

• The Health-Related Quality of Life in children and adolescents - revised

  The Health-Related Quality of Life in children and adolescents - revised (KINDL-R) measure key aspects of health related quality of life in children and adolescents. Separate questionnaires for ages 7-13 and 14-17 exist. A translated Danish version of the KINDL is available. This scale provides a more general evaluation of the young patient's overall well-being and thriving in several life areas: physical, emotional, self-esteem, family, friends, and school, representing the child's experiences during the past week. Each item is rated on a five-point Likert scale and all scores are transformed to a scale ranging from 0 to 100. All subscale scores are added together to form a total score, with higher scores indicating better outcome. The questionnaire has a disorder-related subscale that reflects the child's experience of OCD-related burden and this is not part of the total score. The primary outcome used in the present study is the KINDL-R self-report total score.

  Post-booster-treatment (at termination of booster treatment - 3 months after the last session in the intensive treatment period)

• The Health-Related Quality of Life in children and adolescents - revised

  The Health-Related Quality of Life in children and adolescents - revised (KINDL-R) measure key aspects of health related quality of life in children and adolescents. Separate questionnaires for ages 7-13 and 14-17 exist. A translated Danish version of the KINDL is available. This scale provides a more general evaluation of the young patient's overall well-being and thriving in several life areas: physical, emotional, self-esteem, family, friends, and school, representing the child's experiences during the past week. Each item is rated on a five-point Likert scale and all scores are transformed to a scale ranging from 0 to 100. All subscale scores are added together to form a total score, with higher scores indicating better outcome. The questionnaire has a disorder-related subscale that reflects the child's experience of OCD-related burden and this is not part of the total score. The primary outcome used in the present study is the KINDL-R self-report total score.

  6 months follow-up

• The Health-Related Quality of Life in children and adolescents - revised

  The Health-Related Quality of Life in children and adolescents - revised (KINDL-R) measure key aspects of health related quality of life in children and adolescents. Separate questionnaires for ages 7-13 and 14-17 exist. A translated Danish version of the KINDL is available. This scale provides a more general evaluation of the young patient's overall well-being and thriving in several life areas: physical, emotional, self-esteem, family, friends, and school, representing the child's experiences during the past week. Each item is rated on a five-point Likert scale and all scores are transformed to a scale ranging from 0 to 100. All subscale scores are added together to form a total score, with higher scores indicating better outcome. The questionnaire has a disorder-related subscale that reflects the child's experience of OCD-related burden and this is not part of the total score. The primary outcome used in the present study is the KINDL-R self-report total score.

  12 months follow-up

• The Health-Related Quality of Life in children and adolescents - revised

  The Health-Related Quality of Life in children and adolescents - revised (KINDL-R) measure key aspects of health related quality of life in children and adolescents. Separate questionnaires for ages 7-13 and 14-17 exist. A translated Danish version of the KINDL is available. This scale provides a more general evaluation of the young patient's overall well-being and thriving in several life areas: physical, emotional, self-esteem, family, friends, and school, representing the child's experiences during the past week. Each item is rated on a five-point Likert scale and all scores are transformed to a scale ranging from 0 to 100. All subscale scores are added together to form a total score, with higher scores indicating better outcome. The questionnaire has a disorder-related subscale that reflects the child's experience of OCD-related burden and this is not part of the total score. The primary outcome used in the present study is the KINDL-R self-report total score.

  24 months follow-up

• The Health-Related Quality of Life in children and adolescents - revised

  The Health-Related Quality of Life in children and adolescents - revised (KINDL-R) measure key aspects of health related quality of life in children and adolescents. Separate questionnaires for ages 7-13 and 14-17 exist. A translated Danish version of the KINDL is available. This scale provides a more general evaluation of the young patient's overall well-being and thriving in several life areas: physical, emotional, self-esteem, family, friends, and school, representing the child's experiences during the past week. Each item is rated on a five-point Likert scale and all scores are transformed to a scale ranging from 0 to 100. All subscale scores are added together to form a total score, with higher scores indicating better outcome. The questionnaire has a disorder-related subscale that reflects the child's experience of OCD-related burden and this is not part of the total score. The primary outcome used in the present study is the KINDL-R self-report total score.

  36 months follow-up

Secondary Outcomes (6)

• The Clinical Global Impression Scale

  Pre-wait/pre-treatment; Post-wait/pre-treatment; Mid-intensive-treatment; Post-intensive-treatment; Post-booster-treatment; 6 months follow-up; 12 months follow-up; 24 months follow-up; 36 months follow-up

• The Children's Global Assessment Scale

  Pre-wait/pre-treatment; Post-wait/pre-treatment; Mid-intensive-treatment; Post-intensive-treatment; Post-booster-treatment; 6 months follow-up; 12 months follow-up; 24 months follow-up; 36 months follow-up

• The Child Obsessive Compulsive Impact Scale - Child and Parent Versions - Revised (COIS-R-C/P)

  Pre-wait/pre-treatment; Post-wait/pre-treatment; Mid-intensive-treatment; Post-intensive-treatment; Post-booster-treatment; 6 months follow-up; 12 months follow-up; 24 months follow-up; 36 months follow-up

• The Screen for Child Anxiety Related Emotional Disorders

  Pre-wait/pre-treatment; Post-wait/pre-treatment; Mid-intensive-treatment; Post-intensive-treatment; Post-booster-treatment; 6 months follow-up; 12 months follow-up; 24 months follow-up; 36 months follow-up

• The Mood and Feelings Questionnaire

  Pre-wait/pre-treatment; Post-wait/pre-treatment; Mid-intensive-treatment; Post-intensive-treatment; Post-booster-treatment; 6 months follow-up; 12 months follow-up; 24 months follow-up; 36 months follow-up

Other Outcomes (5)

• The Obsessive Beliefs Questionnaire - child version

  Pre-wait/pre-treatment; Post-wait/pre-treatment; Mid-intensive-treatment; Post-intensive-treatment; Post-booster-treatment; 6 months follow-up; 12 months follow-up; 24 months follow-up; 36 months follow-up

• The Obsessive Compulsive Inventory - child version

  Pre-wait/pre-treatment; Post-wait/pre-treatment; Mid-intensive-treatment; Post-intensive-treatment; Post-booster-treatment; 6 months follow-up; 12 months follow-up; 24 months follow-up; 36 months follow-up

• The Mini Youth OCD Scale

  Pre-wait/pre-treatment; Post-wait/pre-treatment; Mid-intensive-treatment; Post-intensive-treatment; Post-booster-treatment; 6 months follow-up; 12 months follow-up; 24 months follow-up; 36 months follow-up

Study Arms (1)

Group CBT

EXPERIMENTAL

Group cognitive behavioral therapy for obsessive compulsive disorder in youth

Other: Cognitive behavioral therapy

Interventions

Cognitive behavioral therapy OTHER

The G-CBT manual for adolescents has been developed in the OCD-clinic in Aarhus and pilot tested in Aarhus. The G-CBT manual is based on the NordLOTS I-CBT manual in overall content and structure, with a few additional elements added with inspiration from previous individual and group CBT literature as well as the author's ideas. The main therapeutic ingredient is exposure and response prevention. The manual is made up of three individual family sessions, 13 weekly adolescent group sessions, three parent group sessions and two adolescent group booster sessions.The manual contains detailed guiding of therapists for each session and a comprehensive collection of working sheets for the adolescents to be used during sessions.

Group CBT

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• to 17 years of age
• A primary diagnosis of OCD according to Schedule for Affective Disorders and Schizophrenia for School-Age Children - Present and Lifetime version for DSM-IV (K-SADS-PL).
• Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)24 total score ≥ 16.

You may not qualify if:

• meet the criteria for an intellectual disability (IQ \< 70),
• meet the criteria for psychotic disorder according to DSM-5,
• meet the criteria for Asperger's, or Autistic syndrome with a Clinical Global Impression Scale - Severity (CGI-S) rating ≥ 4 or same or higher rating than CGI-S for OCD
• meet the criteria for PDD-NOS with a Clinical Global Impression Scale - Severity (CGI-S) rating ≥ 4 or same or higher rating than CGI-S for OCD
• meet the criteria for any co-occurring mental disorder according to the Diagnostic and statistical manual of mental disorders (DSM-5) with a CGI-S rating higher than CGI-S for OCD, indicating that OCD is not the primary treatment priority
• have inadequate Danish language proficiency or both parents have inadequate Danish language proficiency

Sponsors & Collaborators

• Aarhus University Hospital: lead
• Jascha Fonden: collaborator
• Region midtjyllands sundhedsvidenskabelige forskningsfond: collaborator
• Sygekassernes Helsefond: collaborator
• Region Midtjyllands Psykiatriske Forskningsfond: collaborator

Study Sites (1)

Katja Anna Hybel

Aarhus, 8200, Denmark

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Katja A Hybel, PhD

  Aarhus University Hospital, Psychiatry, Department of Child and Adolescent Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior researcher, PhD

Study Record Dates

• First Submitted: May 2, 2021
• First Posted: May 18, 2021
• Study Start: August 15, 2017
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: September 27, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)